"A clear understanding of the types of procedures that a facility performs is the most important factor in gown selection," explained Judson Boothe, marketing director of medical supplies for Kimberly-Clark Health Care, Roswell, GA. "Procedures of varying length, complexity and exposure pose different levels of risk for strikethrough, linting, fire, etc., which should be drivers of purchasing decisions around any type of protective apparel. For example, caregivers involved in a fluid-intensive orthopedic procedure will have very different requirements from those performing a lower-fluid, shorter duration hernia repair."

In addition to orthopedic surgeries, other procedures that put patients at an especially high risk for surgical site infections and thus require drapes with higher levels of barrier protection include cardiovascular and cesarean procedures, said Shawn L. Matalas, technical service representative, 3M Medical Division, St. Paul, MN.

Caroline Gullion, product manager, surgical apparel, Cardinal Health, Dublin, OH, described how the four levels of liquid barrier protection developed by the Association for the Advancement of Medical Instrumentation (AAMI) translate to real-world applications. "It’s estimated that clinicians in 30 percent of all surgical procedures should wear an AAMI Level 4, fully impervious surgical gown and drape. Those involved in the remaining 70 percent of procedures should wear an AAMI Level 3 surgical gown. Healthcare workers exposed to even minimal amounts of fluid during surgical procedures should avoid AAMI Level 1 or 2 gowns because they won’t likely offer the necessary level of protection."

Kimberly-Clark’s KC100 gown

She added, "There are times when a moderate-fluid procedure requires a change in technique because of the increase in fluid intensity. In an effort to reduce surgical site infections in those instances, clinicians should look for a gown with increased levels of protection and the lowest lint particles possible."

Frank Czajka, president, Proxima Division, Medline Industries Inc., Mundelein, IL, agreed that even with the move towards more minimally invasive surgeries, fluid resistance is critical. "You never know when a procedure’s going to go from minimally invasive to open," he said.

In addition to being resistant to penetration by blood and body fluids, other important performance characteristics for surgical gowns and drapes as recommended by the Association of periOperative Registered Nurses include strength and durability, comfort, drapeability, flame resistance and abrasion resistance.

"Low-linting gowns and drapes are critical, especially when there is a lot of movement of the patient and by the caregivers, which can disrupt lint particles and cause them to fall into and contaminate the incision," said Boothe. "Purchasing criteria should include the gown’s and drape’s ability to withstand a great deal of rubbing and abrasion throughout a procedure without generating particulate contaminants and airborne bacterial transmission."

"The combination of oxygen and use of lasers and other electrical instruments can certainly pose a risk of fire in the OR; fire can ignite unexpectedly and be catastrophic for the patient and staff. One way that caregivers can minimize their risk is by selecting gowns and drapes that have the maximum rating for flame resistance," added Boothe.

On+Qor reusable surgical gown

Doug Robards, senior market manager, Convertors Surgical Drapes, Cardinal Health, noted that "because virtually all drapes are AAMI Level 4 (impervious around the fenestration), there are a number of other important factors that should be taken into account when selecting drapes, including:

• Size and design – Because coverage of the patient is critical to creating an appropriate sterile field, the size and proportion of the drape is very important to consider. Procedure-specific drapes should cover the patient entirely, from the finger tips to the toes. Any areas not covered by the drape should be covered with additional non-fenestrated drapes.

• Shape and size of the fenestration – Surgeons can avoid having to modify a drape with scissors by selecting a drape that features a fenestration located in the appropriate spot and providing the correct amount of incision point access.

• Fluid direction or control – There are a number of features on surgical drapes that enable fluid management. The first of these mechanisms is the reinforcement around the fenestration, which should absorb fluid fast enough to prevent it from reaching the base fabric of the drape and be large enough to hold a sufficient amount of fluid so that it doesn’t reach capacity. Other important fluid management features of drapes are pouches and troughs, which vary in size and shape by procedure and often contain ports that allow for a suction hose to be attached to remove fluid from the surgical field."

The fluid control pouches and absorbent pads featured on 3M’s drapes help "channel and collect body and irrigation fluids, reducing patient exposure and minimizing fluid run-off which can be a hazard to OR staff," said Matalas.

Precept Medical drape and gown

Adhesive apertures also help prevent drape migration into the operative site reducing the risk of contamination. 3M Ioban 2 Antimicrobial Incise Film drapes provide superior drape adhesion to the skin, have continuous broad-spectrum antimicrobial activity in the drape adhesive where it can’t be washed away, and are clinically proven to help reduce the risk of wound contamination and bacterial migration.

The new 1034 Central Venous Catheter drape from 3M features multiple apertures with clear plastic around each aperture. "The adhesive apertures keep the drape from migrating, while the clear window provides maximum visualization of the insertion site. 3M strives to meet or exceed the guidelines, standards and recommendations initiated in our industry, such as the CDC guidelines for central line insertion that recommend a full body drape and the use of sterile techniques to help reduce the risk of infection," explained Matalas.

BD Medical - Ophthalmic Systems, Waltham, MA, offers drapes that are sterile and ready-to-use, labeled for easy identification with bar codes for product tracking. The Visitec line of drapes are designed with easy-open packages for aseptic transfer and convenient for quick operating room setups. The drapes are low lint producing which is particularly important for ophthalmic surgical procedures. The BD Visitec Visidrape surgical drapes are available in full body, outpatient and minor surgery sizes, with and without fluid collection bags and wicks.

Medline Sahara table drape

Truly functional drapes must adapt to changes in surgery techniques – and one requirement for the growing number of minimally invasive surgeries is line management. Medline offers Velcro-style line holders built into its drapes to help make set-up quick and easy. "You have to have drapes that are designed to manage the lines that come into play with laparoscopic surgery, the light cords, the insufflation cords, the different delivery methods for that surgery to take place," said Czajka. "It’s not open the chest and go in with a scalpel, it’s high tech instrumentation and with that comes power cords, lightsources, you have to be able to manage those."

He added, "Protection is obviously the key when selecting gowns and drapes, but we find that other main attributes are comfort in gowns, both feel and cut as well as drapeability and functional attributes in drapes like fluid and line management."

Innovative fabrics also help up the comfort ante. "It’s exciting to see the advancements that have been made in surgical gowns and drapes," said Boothe. "Certainly, we’ve seen ongoing innovation of protective surgical fabrics, which has raised standards of protection for patient and staff in the OR, as well as drapes with custom sizes and features."

Czajka added, "Fabrics have really advanced making higher barrier gowns that provide excellent comfort. Medline’s Aurora gown made with Dupont Suprel fabric combines the highest level of protection while giving comfort formerly not available in high protection gowns. The overall size of our gown cuts differentiates our product as does the choice of fabrics in surgical gowns. Where competitive products offer one fabric, Medline offers three styles of fabrics (Eclipse (Soft spunlace), Sirus (SMS) and Aurora (Dupont Suprel))." 

Cardinal Health Tiburon surgical drape

"Traditionally, it has been difficult for manufacturers to strike a perfect balance between high barrier protection and extreme levels of comfort, but Cardinal Health was able to achieve just that with its RoyalSilk gown," said Gullion. "RoyalSilk features a unique Spunbond Meltblown Spunbond (SMS) fabric that is soft to the touch and offers improved breathability without sacrificing protection. The RoyalSilk gown offers AAMI Level 3 protection from blood, liquid and other potential infectious material. For those procedures that are high in fluid intensity and require AAMI Level 4 protection, clinicians can select the Cardinal Health SmartGown – which is made with a fully impervious breathable fabric that has a Responsive Membrane allowing water vapor to escape from the inside of the gown, promoting cooling while remaining fully impervious."

Precept Medical’s Precept UltraGard LLC (Arden, NC) offers a wide variety of non-reinforced and reinforced surgeon gowns to meet surgeons’ and clinicians’ comfort and protection needs. The company’s new line of Excel SMS Surgical Gowns are generously sized in the chest and underarm area. This offers the wearer the ease of movement of raglan sleeve gowns with the added protection and design of ‘seams on top’ set-in sleeves. Precept UltraGard LLC Surgical Patient Drapes are available in two blue fabrics, SMS and Dupont Softesse spunlace material, for virtually any procedure.

BD ophthalmology drape

While skimping on barrier protection is never a viable option, there are ways to keep gown and drape costs under control. Evaluating utilization trends might be the best place to start suggested Czajka. "You can absolutely save money while providing excellent protection. Looking at utilization and choosing the correct level of protection are vital. Many users choose products that are overkill for applications or wear sizes that are too large which cost a facility more. In addition, fabrics are providing higher barrier at lower weights which allow for the ability to deliver top quality product at a good value." To help facilities better identify their needs and streamline SKUs, Medline offers a comprehensive gown selection guide that takes into account fluid level, comfort needs and sizing.

Kimberly-Clark recently organized all of their surgical gowns and drapes into three performance classes that correspond with certain levels of protection: KC 100, KC 200 and KC 300. "There does not have to be a trade-off between adequate protection and supply costs," said Boothe. "This balance was precisely the reason why we developed our tiered approached to the surgical apparel portfolio. By being able to select the right barrier for the procedure at hand – nothing more, nothing less – materials managers can feel confident that they’re protecting their patients and staff with the best possible product while not overspending on gowns or drapes that are unnecessary. The Kimberly-Clark Color Key also addresses this issue by ensuring that caregivers know exactly what type of gown they’re donning, thereby reducing waste associated with incorrectly selecting the wrong gown."

Kimberly-Clark’s KC200 surgical drape

Likewise, choosing the right drape for the procedure can also help to keep costs in check by reducing the need to layer drapes in order to achieve a perceived higher level of protection. "Recognizing the importance of enlarging the critical zone, many surgeons layer drapes to reduce the chance of strike-through," said Matalas. "In fact, surgeons say that the main reason they layer when draping is to create a barrier. Transition from drape layering to a one piece specialty or procedural sheet is being recognized for time saving efforts, standardization in draping techniques and fewer inventory SKUs."

"3M Absorbent Impervious Material is absorbent and impervious throughout the entire drape," noted Matalas. "A drape that is absorbent and impervious is designed to help prevent the risks of both strike-through and roll-off, and eliminates the need for layering while protecting the healthcare worker."

"We encourage hospitals to look at ways of streamlining their purchasing and supply stock through ORUR’s, which are utilization reviews designed to help hospitals determine the best mix of products and, in the process, reduce supply waste and unnecessary spending," Boothe suggested.

While the vast majority of hospitals use disposable gown and drape products (Czajka estimated that single-use products make up 90 percent of the market) you might be wondering whether reusable products are a good way to go green and possibly save money at the same time. Several vendors commented on the financial, environmental and infection prevention implications.

"Although much is made of the difference between the landfill space required for the disposal of single use garments compared to that of reusable garments (which are also ultimately discarded), the total environmental impact of the use of both of these options must be considered before determining if one has a lesser impact on the earth’s resources," said Gullion. "A way to truly compare the impact is by converting the resources required for the manufacture, usage and disposal of the products to a common measurement. This is necessary because it is difficult to compare a pound of water usage, for example, to a pound of landfill waste. Once such scale is the Universal Environmental Burden Index, which translates all pollutants into an index with the measurement being pounds of burden. On this scale, for instance, a pound of CO2 emission equals one pound of burden, but one pound of NOx equals 100 pounds of burden, due to the fact that it has a much greater negative impact on the environment."

"When comparing the environmental burden of reusable garments to that of disposable garments, the disposable garments can actually have a lower environmental burden. This is mainly due to the fact that processing reusable garments requires a significant amount of energy and water to make them available for the next surgery. The use of water is especially critical in water-deficit and drought regions."

According to Czajka it takes one and a half gallons of water to launder one surgical gown, and as much as four gallons of water to launder a reusable drape. With Medline supplying approximately 4.6 million single-use gowns and 4.3 million drapes a month to the surgical market, "using Medline disposable drapes and gowns helps conserve over 286 million gallons of water and the disposable marketplace as a whole conserves over 750 million gallons of water," he estimated. "That’s not taking into account the chemicals that are used to eliminate biohazards from the waste that’s on the reusable products. They’re not friendly chemicals."

Infection control issues are also a consideration. "After taking into account the true environmental impact of both reusable and disposable surgical gown options, hospitals should also take into account the efficacy of the product," said Gullion. "The reason that reusable gowns are retired after a designated number of wearing and washings is that the barrier performance of the fabric degrades after each usage cycle. There is an unpredictable level of barrier for reusable garments, but single use gowns provide the same level of fluid resistance each time they are used."

"I think it’s a misconception that disposables are bad for the environment," said Czajka. "For instance Medline’s Eclipse products are over 55 percent biodegradeable, are made of a renewable resource, and salvages the off-cutting of the lumber industry to make it into a high grade of paper, so you’re actually eliminating waste from lumber farming. The pulp suppliers also plant three trees for every one harvested to make the product."

Boothe commented, "Environmental considerations are a part of virtually all of our R & D activities related to supplies. For many years, Kimberly-Clark has focused these efforts on manufacturing processes, material selection for product development, and packaging innovations to reduce space and waste. But when it comes to gowns, we feel that disposable is the best option for preventing infection."

According to Mary Faith Tamborino, general manager, on+qor division of All-Pak, Bridgeville, PA. "The most unique characteristic of the on+qor [reusable] OR gown is that the protection we offer comes with comfort for the healthcare professional wearing them. Our gowns ‘breathe’."